Pilot Study of Nilogen 3D-EX and Its Ability to Predict Therapeutic Response to Anti-PD1 or Anti-PDL1 in NSCLC

NCT03371992 | Unknown Early Phase 1 FDA Drug

• 1 other identifier: NO88352235
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Subjects will be eligible for this study if they are about to start on a drug called nivolumab for lung cancer. Some patients' cancers respond to nivolumab but a majority of patients do not. To better determine which patients will most likely respond to nivolumab or not, the investigators are testing an assay that tests biopsy tissue to determine if the subject's tumor will likely respond to nivolumab. The main purpose of this research study is to see if this specialized test can help identify people with locally advanced or metastatic non-small cell lung cancer who are more likely to benefit from treatment with nivolumab. The results of the tests will not affect whether or not subjects receive nivolumab but may help identify future patients who are more likely to benefit from nivolumab. The study assay is extra and experimental.

Conditions

Non Small Cell Lung Cancer

Keywords

immunotherapy; anti-PD1; anti-PDL1; biomarker; drug mechanism

Outcome Measures

Primary Outcomes (1)

• Evaluation of target lesions by RECIST

  Complete Response (CR) is defined as disappearance of all target lesions Partial Response (PR) is defined as at least a 30% decrease in the sum of longest dimension (LD) of target lesions taking as reference the baseline sum LD Progressive Disease (PD) is defined as at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started

  Tumor size is assessed via CT every 8 weeks and RECIST criteria will be documented every 8 weeks after the first treatment for progression or date of death, whichever comes first, for up to 60 months.

Study Arms (1)

Lung Cancer Patients

OTHER

Lung cancer patients receiving one of three standard of care immunotherapy drugs including nivolumab, pembrolizumab or atezolizumab. 3D-EX will be performed on biopsies from patients enrolled in the study to correlate with the patient's evaluation of response by RECIST.

Drug: Nivolumab; Diagnostic Test: 3D-EX; Other: Evaluation of Response by RECIST

Interventions

Nivolumab DRUG

Nivolumab, pembrolizumab or atezolizumab will be administered as per the established standard of care for the eligible population.

Also known as: pembrolizumab, atezolizumab

Lung Cancer Patients

3D-EX DIAGNOSTIC_TEST

Analysis of drug-mediated changes in the tumor microenvironment.

Also known as: 3D ex vivo assay

Lung Cancer Patients

Evaluation of Response by RECIST OTHER

Evaluation of tumor response using the set of published rules to determine if a tumor has responded, is stable or progressed during treatments.

Lung Cancer Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible for participation in this trial, the subject must:
• Be willing and able to provide written informed consent for the trial.
• Be at least 18 years of age on the day of signing informed consent.
• Have a histologic or cytologic diagnosis of Stage IV NSCLC.
• Must be medically eligible to receive nivolumab, pembrolizumab or atezolizumab as the standard of care for the next line of therapy (must have previously received first line platinum doublet chemotherapy) as determined by their oncologist.
• Have measurable disease based on RECIST 1.1 (see section 7.1 or appropriate number).
• Be willing and medically fit to undergo a fresh (newly obtained) diagnostic biopsy of a metastatic lesion or primary site of disease before receiving nivolumab, pembrolizumab or atezolizumab. "Fresh (newly-obtained)" is defined as a specimen obtained up to 6 weeks prior to initiation of treatment with nivolumab, pembrolizumab or atezolizumab on Day 1.
• Fit in either of these categories:
• Stage I-III NSCLC patients who develop metastatic disease within 6 months of receiving definitive (curative) treatment that includes platinum-based chemotherapy, and who require biopsy for either confirmation of diagnosis or further molecular or immunohistochemical testing to guide treatment.
• Stage IV NSCLC patients with progression of disease following platinum based chemotherapy, and who require biopsy for either confirmation of diagnosis or further molecular or immunohistochemical testing to guide treatment.
• Stage IV NSCLC patients who will receive nivolumab, pembrolizumab or atezolizumab as the standard of care in special circumstances (eg, when chemotherapy is contraindicated or if a patient declines to be treated with chemotherapy).
• Be willing to undergo at least 4 fine needle aspirations for experimental purposes at the time of the standard of care biopsy.
• Have a performance status of 0 or 1 on the ECOG Performance Scale.

You may not qualify if:

• The subject must be excluded from participating in the trial if the subject:
• Is currently participating in and receiving therapy as part of a different clinical trial.
• Is not a candidate to receive nivolumab, pembrolizumab or atezolizumab as determined by the patient's oncologist.
• Has an active infection requiring systemic therapy.
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might; (1) confound the results of the trial, (2) that would substantially increase risk of incurring adverse events (AEs) from nivolumab, pembrolizumab or atezolizumab, (3) that would interfere with the subject's participation for the full duration of the trial, or (4) is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Is pregnant or breastfeeding.
• Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
• Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected).

Sponsors & Collaborators

• Nilogen Oncosystems: lead
• Henry Ford Health System: collaborator

Study Sites (1)

Henry Ford Health Systems

Detroit, Michigan, 48202, United States

Location

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Nivolumab; pembrolizumab; atezolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Soner Altiok, MD, PhD

  Nilogen Oncosystems

  PRINCIPAL INVESTIGATOR

• Igor Rybkin, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2017
• First Posted: December 13, 2017
• Study Start: March 9, 2018
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)